| Drug ID: | Drug26 |
|---|---|
| Drug Name: | Mesalazine |
| CID: | 4075 |
| DrugBank ID: | DB00244 |
| Modality: | Small Molecule |
| Groups: | approved |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT05992142, , NCT01532648, , NCT02665845, , NCT00603733, , NCT02683759, , NCT03804931, , NCT01320436, , NCT00984568, , NCT00167882, , NCT00713310, , NCT01004185, , NCT01903252, , NCT00151892, , NCT00349388, , NCT05753267, , NCT05781698, , NCT05988528, , NCT05567068, , NCT05986136, , NCT05119 |
| Molecular Formula: | C7H7NO3 |
| Molecular Weight: | 153.14 g/mol |
| Isomeric SMILES: | C1=CC(=C(C=C1N)C(=O)O)O |
| Synonyms: | 5-Aminosalicylic acid; mesalamine; Mesalazine; 89-57-6; 5-Amino-2-hydroxybenzoic acid; 5-ASA; m-Aminosalicylic acid; Lialda; Fisalamine; Apriso |
| Phase 0: | 1 |
| Phase 1: | 39 |
| Phase 2: | 43 |
| Phase 3: | 94 |
| Phase 4: | 27 |
| Description: | An anti-inflammatory agent, structurally related to the salicylates, which is active in inflammatory bowel disease. It is considered to be the active moiety of sulphasalazine. (From Martindale, The Extra Pharmacopoeia, 30th ed) |
Molecular Structure
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt238 | 4075 | Mesalamine | 3028 | HSD17B10 | Homo sapiens (human) | None | |
| dt239 | 4075 | Mesalamine | 2744 | GLS | Homo sapiens (human) | None | |
| dt240 | 4075 | Mesalamine | 3586 | IL10 | Homo sapiens (human) | None | |
| dt241 | 4075 | Mesalamine | 5743 | PTGS2 | Homo sapiens (human) | Inhibitor | |
| dt242 | 4075 | Mesalamine | 5742 | PTGS1 | Homo sapiens (human) | Inhibitor | |
| dt243 | 4075 | Mesalamine | 240 | ALOX5 | Homo sapiens (human) | Inhibitor | |
| dt244 | 4075 | Mesalamine | 5468 | PPARG | Homo sapiens (human) | Agonist | |
| dt245 | 4075 | Mesalamine | 1147 | CHUK | Homo sapiens (human) | Inhibitor | |
| dt246 | 4075 | Mesalamine | 3551 | IKBKB | Homo sapiens (human) | Inhibitor | |
| dt247 | 4075 | Mesalamine | 4843 | NOS2 | Homo sapiens (human) | 17503181 | Inhibitor |
- No data available
Phase Distribution
Phase Description
- Phase 0: Exploratory trials to assess drug behavior in humans
- Phase 1: Safety trials to determine safe dosage range
- Phase 2: Efficacy trials to evaluate therapeutic effects
- Phase 3: Large-scale trials to confirm efficacy and safety
- Phase 4: Post-marketing surveillance for long-term safety and efficacy
| Trial ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| NCT02093663 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | Shire | Ulcerative Colitis | DRUG: MMX Mesalamine/Mesalazine (Low Dose)|DRUG: … | Details |
| NCT01011322 | A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis | PHASE2 | UNKNOWN | Lipid Therapeutics GmbH | Ulcerative Colitis|Large Intestine|Diarrhea|Abdom… | DRUG: LT-02|DRUG: placebo | Details |
| NCT04133194 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | PHASE4 | RECRUITING | Flemming Bendtsen | Ulcerative Colitis | DRUG: Mesalazine|DRUG: Mesalazine | Details |
| NCT01257386 | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | PHASE3 | COMPLETED | Tillotts Pharma AG | Active Ulcerative Colitis | DRUG: Asacol|DRUG: Mesalazine | Details |
| NCT06176560 | Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis. | PHASE3 | NOT_YET_RECRUITING | Faes Farma, S.A. | Colitis, Ulcerative | DRUG: Mesalazine | Details |
| NCT00708656 | The Colitis Once Daily Asacol Study | PHASE3 | COMPLETED | Cardiff and Vale University Health Board | Ulcerative Colitis | DRUG: mesalazine (Asacol) | Details |
| NCT00151944 | Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. | PHASE3 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: SPD476 (mesalazine) | Details |
| NCT00747110 | Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC) | PHASE3 | COMPLETED | Dr. Falk Pharma GmbH | Colitis, Ulcerative | DRUG: budesonide|DRUG: mesalazine | Details |
| NCT01257399 | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | PHASE3 | COMPLETED | Tillotts Pharma AG | Ulcerative Colitis in Remission | DRUG: Asacol|DRUG: Mesalazine | Details |
| NCT05386290 | A Multicentered Prospective Cohort Study of Chinese IBD Patients | None | UNKNOWN | Peking Union Medical College Hospital | Ulcerative Colitis|Crohn Disease | DRUG: Infliximab|DRUG: Vedolizumab|DRUG: Ustekinu… | Details |
| NCT01124149 | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis | PHASE4 | COMPLETED | Shire | Ulcerative Colitis | DRUG: MMX mesalamine/ mesalazine | Details |
| NCT00503243 | Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: Delayed and extended release mesalazine | Details |
| NCT00449722 | OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis | PHASE3 | COMPLETED | Dr. Falk Pharma GmbH | Ulcerative Colitis | DRUG: mesalazine | Details |
| NCT00737789 | Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. | PHASE3 | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: Mesalazine slow-release granules|DRUG: Mesa… | Details |
| NCT02368717 | An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase | PHASE3 | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: Mesalazine Enema|DRUG: Placebo Enema | Details |
| NCT00808977 | A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis | PHASE2 | COMPLETED | Palau Pharma S.L.U. | Ulcerative Colitis | DRUG: Dersalazine sodium|DRUG: Mesalazine|DRUG: P… | Details |
| NCT02537210 | Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis | None | COMPLETED | Chinese University of Hong Kong | Colitis, Ulcerative|Aminosalicylic Acid | DRUG: Mesalazine|DRUG: Placebo oral capsule | Details |
| NCT00545389 | Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 | PHASE2 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: SPD476 is a polymeric matrix formulation th… | Details |
| NCT02261636 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | None | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: mesalazine | Details |
| NCT03917095 | The Safety and Efficacy of TET Enema in the Treatment of UC | None | UNKNOWN | The Second Hospital of Nanjing Medical University | Ulcerative Colitis Chronic Mild|Ulcerative Coliti… | DEVICE: The Colonic Transendoscopic enteral Tubin… | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S01 | Anti-inflammatory | inflammatory | 5-Aminosalicylates (5-ASAs); corticosteroids | Crohn's disease and ulcerative colitis are the two main com… | Details |
High-dose mesalazine treatment for ulcerative colitis patients who relapse unde…
PMID: 21195041
Year: 2011
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Mesalazine is often used to maintain remission in patients with ulcerative colitis. AIM: To investigate if increasing the dose of mesalaz…
A case of pyoderma gangrenosum with ulcerative colitis treated with mesalazine
PMID: 21165212
Year: 2010
Relationship Type:
Treatment
Score: 6.1
Pyoderma gangrenosum (PG) manifests as recurrent deep ulceration of the skin and PG is associated with a variety of disorders. Approximately 30% of t…
Mesalazine vanishing time from rectal mucosa following its topical administrati…
PMID: 21122491
Year: 2010
Relationship Type:
Treatment
Score: 6.1
To investigate how long and how much Mesalazine (M) is available inside the rectal mucosa following its topical instillation, in patients (pts) with …
Best practice in the management of mild-to-moderately active ulcerative colitis…
PMID: 20665988
Year: 2010
Relationship Type:
Treatment
Score: 6.1
Optimizing treatment goals in ulcerative colitis requires recognizing the needs of patients. It is increasingly recognized that adapting treatment st…
Azathioprine versus mesalazine for prevention of postoperative clinical recurre…
PMID: 20551460
Year: 2010
Relationship Type:
Treatment
Score: 6.1
OBJECTIVE: The aim of the study was to compare azathioprine versus mesalazine tablets for the prevention of clinical recurrence in patients with post…
Mesalazine-induced multi-organ hypersensitivity
PMID: 20441247
Year: 2010
Relationship Type:
Treatment
Score: 6.1
Mesalazine therapy for ulcerative colitis has been reported to be effective and safe. Rare cases of mesalazine-induced renal, pancreatic, myo-pericar…
A cost-effectiveness analysis of MMX mesalazine compared with mesalazine in the…
PMID: 20141380
Year: 2010
Relationship Type:
Treatment
Score: 6.1
OBJECTIVES: To perform a cost-utility analysis of a new formulation of mesalazine (Mezavant XL, MMX mesalazine) versus an existing oral mesalazine (A…
Lab-on-a chip electrochemical sensing platform for simultaneous, ultra-sensitiv…
PMID: 40267767
Year: 2025
Relationship Type:
Treatment
Score: 5.5
Mesalamine or 5-aminosalicylic acid (5-ASA) and its isomer 4-aminosalicylic acid (4-ASA), well known key therapeutic agents used to treat inflammator…
Mucoadhesive Mesalamine Prodrug Nanoassemblies to Target Intestinal Macrophages…
PMID: 38867457
Year: 2024
Relationship Type:
Treatment
Score: 5.5
While mesalamine, a 5-aminosalicylic acid (5-ASA), is pivotal in the management of inflammatory bowel disease (IBD) through both step-up and top-down…
Oxidation of Mesalamine under Phenoloxidase- or Peroxidase-like Enzyme Catalysis
PMID: 38138595
Year: 2023
Relationship Type:
Mechanism
Score: 5.5
Mesalamine, also called 5-ASA (5-aminosalicylic acid), is a largely used anti-inflammatory agent and is a main choice to treat Ulcerative Colitis. Th…
Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis
PMID: 32786164
Year: 2020
Relationship Type:
Treatment
Score: 5.5
BACKGROUND: Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its …
The culprit of mesalamine intolerance: case series and literature review
PMID: 31366329
Year: 2019
Relationship Type:
Treatment
Score: 5.5
BACKGROUND: Mesalamine is a first-line drug in the treatment of inflammatory bowel diseases, while its intolerance occasionally occurs in clinical pr…
Effect of Long-Term Mesalamine Therapy on Cancer-Associated Gene Expression in …
PMID: 30478770
Year: 2019
Relationship Type:
Treatment
Score: 5.5
BACKGROUND: The role of 5-aminosalicylic acid (5-ASA or mesalamine) in the prevention of colorectal cancer in ulcerative colitis (UC) patients was re…
5-ASA induced interstitial nephritis in patients with inflammatory bowel diseas…
PMID: 35488310
Year: 2022
Relationship Type:
Treatment
Score: 5.5
BACKGROUND: Acute interstitial nephritis (AIN) is an important cause of kidney injury accounting for up to 27% of unexplained renal impairment. In up…
Modelling the benefits of an optimised treatment strategy for 5-ASA in mild-to-…
PMID: 35165124
Year: 2022
Relationship Type:
Treatment
Score: 5.5
OBJECTIVES: 5-aminosalicylate (mesalazine; 5-ASA) is an established first-line treatment for mild-to-moderate ulcerative colitis (UC). This study aim…
First report of mesalamine (5-aminosalicylic acid) as the causative agent in a …
PMID: 28329471
Year: 2017
Relationship Type:
Mechanism
Score: 5.3
Acute generalized exanthamous pustulosis (AGEP)is a rare eruption of non-follicular sterile pustuleson a diffuse background of erythema and edema,com…
Antioxidant properties of mesalamine in colitis inhibit phosphoinositide 3-kina…
PMID: 23867870
Year: 2013
Relationship Type:
Mechanism
Score: 5.1
BACKGROUND: Mesalamine, 5-aminosalicylic acid (5-ASA), is a potent antioxidant and is known to enhance peroxisome proliferator-activated receptor gam…
A random urine test can identify patients at risk of mesalamine non-adherence: …
PMID: 23295279
Year: 2013
Relationship Type:
Treatment
Score: 5.1
OBJECTIVES: Mesalamine non-adherence is common among patients with ulcerative colitis (UC), and can be difficult to identify in practice. We sought t…
Medication use patterns and predictors of nonpersistence and nonadherence with …
PMID: 23206213
Year: 2012
Relationship Type:
Treatment
Score: 5.1
BACKGROUND: 5-aminosalicylic acid (5-ASA) is the recommended first-line treatment for active mild-to-moderate ulcerative colitis (UC) and for mainten…
Update on the management of ulcerative colitis: treatment and maintenance appro…
PMID: 22888278
Year: 2012
Relationship Type:
Treatment
Score: 5.1
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon that typically manifests as diarrhea, abdominal pain, and bloody stool. Compli…